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Quick Guide to FDA’s Draft Guidance on 3D Printed Devices

A new leapfrog guidance from FDA gives a glimpse into the agency’s thinking on 3D printed medical devices.

On May 10, 2016, FDA released a leapfrog guidance document on the technical considerations for additive manufactured or 3D printed devices. Leapfrog guidance documents provide valuable information on what is in the regulatory pipeline and allow interested parties to have a voice in the development of FDA guidance.